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U.S. Department of Health and Human Services

Medical Devices

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ConMed Linvatec - Universal Cables

Recall Class: Class I
Date Recall
Initiated:
July 31, 2009
Product:

Universal Cables, MC5057

The lot numbers affected by this recall are included in this attachment. The cables have date codes etched on one end of the cable and range from JAN-01 to NOV-06 representing the month and the year.

Attachment: Universal Cable Serial Numbers, Excel (158kb)

These cables were manufactured from January 3, 2001 through November 30, 2006 and distributed from January 24, 2001 through February 27, 2009.

See related Linvatec Class I recall

Use: The cable connects Linvatec MicroChoice Small Bone, MicroChoice, and Power Pro Electric I and II Large Bone System electric handpieces to the power source.
Recalling Firm: Linvatec Corporation doing business as (dba) ConMed Linvatec
11311 Concept Boulevard
Largo, Florida 33773-4908
Reason for Recall: The cable may cause the electric handpiece to self-activate.
Public Contact:

ConMed Linvatec Customer Service
1-800-237-0169
Monday-Friday, 7 AM to 7 PM Eastern Time
 

For more information, see Useful Links below.

FDA District: Florida
FDA Comments:

The company sent a letter to their customers with the following instructions:

  • Inspect the cords for signs of excessive wear or damage.
  • Stop using the cable if damaged or worn and replace it immediately.
  • Stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs. Return the cable and handpiece to the company for evaluation.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: